A low-tech toothbrush and so much more

Believe it or not, I grew up without ever using a regular toothbrush until I was about 9 years old. You see, we had a couple of “neem” trees (botanical name: Azadirachta Indica) growing in the backyard of our home in South India. My grandfather would cut little twigs – about the size of toothbrushes – and keep a bunch of them handy. First thing in the morning, I would pop one of these twigs into my mouth and wander around chewing the tip to a pulpy, fibrous brush. No need for toothpaste either. The taste is slightly bitter and astringent but not unpleasant, causing a lot of saliva. By the time I had chewed the tip enough, the stiff fibers of the twig had cleaned out my mouth and teeth as well. The chewed twig is pitched, a fully recyclable and non-polluting, low cost brushing option.

That is just a bit of traditional color from my childhood. The medicinal value of neem extracts in traditional ayurvedic medicine is immense. Depending on who you talk to, the neem trea is a veritable treasure trove that can cure just about everything. All parts of the neem tree (seeds, flowers, bark, leaves) are used in medicinal preparations. Among the better documented uses of the neem tree are:

Neem oils and extracts are used as pesticides against a wide variety of insects, ticks, worms and mites.

Neem oil is an effective mosquito repellent.

Neem extracts are thought to be useful in combating malaria – but this has yet to be proven in rigorous clinical studies.

It is used as a spermicide, for prevention of pregnancy.

Many local brands of cosmetics (soap, shampoo, face creams) advertise they have neem extracts in them since it is considered to be good for maintaining skin elasticity and acne prevention. It is also thought to be effective in the treatment of scabies.

Traditional Indian medicine uses a decoction of neem tree roots to relieve fever. But just like aspirin, its use in children is contra-indicated!

Chewing the leaves or twigs of the neem tree is thought to help control gingivitis, freshen breath and clean teeth.

Extracts of neem leaves may be useful in controlling diabetes.

Of particular interest to me, neem extracts are thought to be of use in controlling GERD (gastric acid reflux disease).

This list is just the tip of the iceberg. Traditional Ayurvedic medicine considers the neem tree a veritable cornucopia of medicinal uses. I have no doubt that with a little web surfing you will be able to find much more detailed information regarding the potential uses of this remarkable tree.

If I stuck around in India until “Ugadi” the South Indian version of lunar New Year rolls around, my mom would feed me a spoonful of a very special traditional chutney first thing on New Year’s day. It would have in it freshly minced neem flowers, along with tamarind, brown sugar, salt and hot chillies. The idea is to capture all five taste groups – bitter, sour, sweet, salty and hot – a reflection of the many facets of life to come in the New Year, each to be welcomed and cherished for its own sake.

Roswel Park Clinical Trial

This is a Phase-I clinical trial. It is not yet ready for recruiting patients, but when it is open 30 or so chemo-naive CLL patients will be recruited. The main aims of the trial are to determine the appropriate dose and establish efficacy, safety and toxicity profiles for neem leaf extract.

Notice the trial excludes patients with high risk cytogenetics, those with 11q or 17p deletions (by FISH test). Rightly so, in my humble opinion. People with high risk disease are not likely to respond to “kinder and gentler” approaches and they are better served by considering more conventional therapy options with proven track records.

“Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens“. In my opinion, this is not just a cautionary CYA statement to be glossed over. Patients in late stage disease are risking something quite real when they participate in early stage trials such as this one. It is called a window of opportunity. Time spent in participating in early stage trials is time taken away from undergoing established therapy options, letting your lymph nodes get larger as you wait and giving your bone marrow that much more time to get clogged up. Judging the right time to treat CLL and the right therapy option that best serves the patient’s needs are exquisitely important decisions.

As usual, the inclusion criteria require adequate liver and kidney function. If you have particular concerns along these lines you should discuss them ahead of time with the investigators. Jaundice (liver toxicity) has been observed in some people ingesting neem oil. Perhaps that concern is not there with neem leaf extract – I do not know. However, if you have had bouts of hepatitis and therefore concerned about the less than robust good health of your liver, this too is something to discuss with the researchers.

Editorial

This article was prompted when several patients wrote to me asking about this clinical trial. If you fulfill the inclusion criteria listed for this clinical trial, I hope you will consider participating in it. Many interesting clinical trials are facing great difficulties in recruiting participants and this has become a serious bottleneck for continuing medical research.

However, I am also a strong believer in the concept of informed consent and people signing up for stuff with their eyes wide open. Patients need to understand what the trial involves, the potential risks of stepping out into uncharted territory. In the case of very early stage trials, there is also the problem of selling ourselves on unproven and overly optimistic expectations.

So, it boils down to this. Why do you wish to participate in an early stage trial?

Given long history of use of many parts of the neem tree in traditional medicine, chances are reasonably good that this neem leaf extract is not likely to have over-the-top-toxicity or adverse effect profile. Are you looking to help clinical research in a situation where there is not likely to be huge personal cost to you, because you have done your due diligence about the drug in question? If so, I salute you. Many future generations of CLL patients will benefit from the altruism and generosity of people like you participating in clinical trials.

But if you are considering an early stage clinical trial as a realistic alternative to proven therapy options, I would like you to keep the following check-list in mind as you consider clinical trial participation:

Early stage clinical trials are designed for the explicit purpose of figuring out if the drug in question works at all in real patients (as opposed to lab rats or CLL cells in a glass dish), how it should be administered and at what dosage. Defining the “dose limiting toxicity” (DLT) is an important aim, since this would used in designing later stage of the drug’s trials.

Explicitly stated in many of the early stage trial consent forms is the statement that these trials are not meant to be of therapeutic benefit to the participants. These early stage trials are truly for the purpose of learning more about the drug in question, they are not meant to replace conventional therapy options for patients and they are certainly not thought to be able to cure anyone.

Maybe, if we are lucky, the trial in question will yield enough interesting data and more confident steps can be taken down the road. But a lot of hard work needs to be done before early stage trials can lead to fully developed therapy options. Less than 1% of early stage clinical trial concepts go on to become realistic success stories.

Just because something is “herbal” does not mean it has no toxicity. Some of our most valuable chemotherapy drugs have herbal origins, and a lot of them also have toxicity to match. Vincristine, one of the ingredients of CHOP therapy regimen used in NHL, comes from the vinca plant. No one who has used vincristine would tell you using it is like walking in the park admiring flowers.

How likely are cancer patients to sell themselves a bill of goods, overestimate the benefits and underestimate the risks involved in early stage clinical trials? “ScienceDaily” reports on the findings of an interesting study:

The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009.

Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials. The authors said that unrealistic optimism has the potential to compromise informed consent “by interfering with the ability to apply information realistically.”

All of us indulge in wishful thinking in our lives. Go ahead, buy that lottery ticket (and if you win big, be sure to share your winnings with me for giving you the suggestion!) But cancer patients considering clinical trial participation should not make their decisions based on wishful thinking. This should be done with clear understanding of the risks and rewards and even more important, with an honest understanding of your own motives for your participation. Do it for the right reasons, do it because it matters, do it because you have thought it through.

15 comments on "The Medicinal “Neem” Tree – CLL Clinical Trial"

molly fletcher

February 4th, 2011 at 5:53 am

Our local Transition Town Group (transition from high carbon to low carbon)is thinking of planting a medicinal garden in our local park. Do you think the Neem tree would grow here in London UK? Or will it only grow in India?
Molly

Chaya Venkat

February 4th, 2011 at 6:00 am

I am afraid it is tropical tree. I believe it grows in many parts of the world, but only in the warm areas. London would be too cold and damp!

mschwalm48

February 4th, 2011 at 8:35 am

Usually plants like this have dozens of biologically active compounds and I wonder if the effort has been made to identify which ones might have an effect on something like CLL. Eliminating some of the more toxic ones could be gentler on the liver and allow higher dosing of the ones that might slow CLL growth. Then again as we have seen so many times combinations of drugs often add up to greater effectiveness than one would guess looking at each one individually. For a large % of CLL patients, extending “watch and wait” could add many quality years to our lives and treating early with benign things like green tea and Neem should be examined. It is so hard to draw conclusions because of the long time periods required to evaluate possible benefits. This sounds like an easy trial but one without much potential financial reward and I’m glad someone is making the effort.

franc

February 4th, 2011 at 12:13 pm

Sounds interesting with potential benefits. Of course I would have to give up my green tea and curcumin and probably the wine. My last batch of green tea from Draco was brown and not orange and perhaps coincidentally my CBCs are not as good as they had been with the old batch. I will discuss the trial with my hem/onc and read more about it. Thanks.

Marina1121

February 4th, 2011 at 12:52 pm

I think all people who will participate in stage 1 trial are heroes. We do not know anything about the safe dosage, but dosage most of the times is VERY important. One year ago, when my WBC reached 120 (while I have been taking green tea and curcummin, which did not help), I started taking magnolia bark extract. Within 3 months the WBC went down to 60. My doctor could not believe it. I got so excited, that I started to go up on the dosage. I wanted to “cure myself” faster. And that’s when the trouble started. My neutrophiles went down to 0, my spleen enlarged, lymphnodes enlarged, platelets went down and I became anemic. I was scared and stopped magnolia extract. Within 2 months my WBC shoot up to 220, my enemia was so severe I had several blood transfusions. That’s when my doctor and I decided to start the REAL treatment. I had FCR lite. After 2 rounds all my nodes and spleen went back to normal and gradually all counts normalized. If I knew I would go through the treatment so well I would not have experimented with something that has not been checked and proven to work which can be very dangerous. But on the other hand, I sometimes think that maybe my treatment worked so well because I was taking all those supplements before and they worked together with traditional treatment. To sum it all up – dosage and protocol are VERY important. Same thing can be a cure or a poison. That is why we should be so grateful to people who conduct those trials and especially to those who participate in them.

Diana

February 4th, 2011 at 1:39 pm

Four years ago when my WBC count was 88 I read about the research at University of Florida with the acai berry. They had done tests in the lab and it had killed 80 percent of leukemia cells. I tried to contact them and find out dosage but did not receive a reply. I started taking packages of frozen acai to make a smoothie and four capsules of freeze dried acai and an acai mix juice with other berries and at the same time taking green tea extract. After two months my WBC count was down to 22. However, over the next year the acai and the green tea were no longer as effective and the WBC continued to slowly increase. Although the cancer cells seemed to get wise to the acai and green tea I still continue the regime because of overall healthful benefits of them. I am grateful for the extra watching and waiting period until I found a more sustainable alternative with the vaccine therapy.

downeyd

February 4th, 2011 at 1:58 pm

This looks like an interesting trial. I’m wondering what the “back story” is for giving the neem tree compound a shot. I understand with green tea that the “idea” behind investigating it came from the observation that cultures where they drink a lot of green tea seemed to have lower rates of cancer. From there it was the discovery of EGCG as the active ingredient and later, a clinical trial. I’ve had CLL for 11 years and try to keep up on what’s out there – but haven’t really seen interest in this evolve over time the way that green tea/magnolia bark has.
Anyone have a capsule history of this in terms of it’s connection to CLL?
I used green tea for close to four years – while my white cell count never went down – it grew very slowly. But my hemoglobin declined steadily. I’d read some anecdotal stuff that said to be aware this could happen. I stopped using it and my white cell count plateaued, my hemoglobin stabilized. Hard to say if there was a cause and effect. I wasn’t at all sorry I tried it, but I’m glad there’s a formal trial for neem so we get some idea of dose & efficacy.
Thanks for bringing this forward Chaya, as always I really appreciate your efforts on behalf of this community.

Dave

Robin Henderson

February 4th, 2011 at 3:55 pm

I so appreciate, Chaya, your thoughtful and scientific approach to all this. I plan on volunteering for the trials. I am a watch and wait with no symptoms and as a lab person, I appreciate the kind of information that clinical trials create.

makahle

February 4th, 2011 at 4:31 pm

I would like to volunteer for something like this Neem. I have had CLL for 7 years now . Still in Watchful waiting period. WBC of around 44. My immuneglobins are low and I’m constantly fighting off colds. Otherwise in great shape to try anything, tried of the waiting and doing nothing !

jandg

February 4th, 2011 at 5:30 pm

Chaya,
Been away from the site for awhile but when I saw this it sparked my interest. I’ve always been one of the ones taking massive supplements (which I know you didn’t always agree with :) when meeting you in Niagara Falls) however everything is holding together after 6 years with no movement. NIH (in the study) reclassified me with MBL so my question is do you think Roswell would take me? Would I need to stop any of my other supps? This is right up my alley and I live in upstate NY so getting to Buffalo wouldn’t be to difficult.
Thanks,
Jim

Chaya Venkat

February 5th, 2011 at 5:58 am

Self-medication with poorly understood and scantily researched herbal products is not a smart way to play the cards we have been dealt. Single person, one-of-a-kind anecdotal stories are of little value to the general patient community, in my opinion.

Happenstance is very much a part of life. Just because you happen to be doing “X” and “Y” happens, it does not follow that “X” caused “Y” to happen. Coincidence does not equate causality.

If however, a large cohort of volunteers in a well designed study do “X” and “Y” happens almost all the time, then there is reason to believe “X” causes “Y”. This is the fundamental difference between anecdotal stories (one or two patients swearing about their personal experience) and well conducted clinical trial results.

Just my two cents, as always.

rwitz18

February 5th, 2011 at 12:59 pm

Chaya,
Such an interesting article. I also enjoy your stories of childhood.
One day, perhaps, we shall share.

Take care and many Blessings

Rita

cedarglass

February 6th, 2011 at 1:31 pm

Dear Chaya,
I cannot tell you how valuable your information has been for me, I thank you with all my soul for your work. I have a problem with mosquito bites and my CLL. Even the smallest of bites causes a terrible reaction to my immune system. I bought some Neem oil to try as a repellent. I have found that Tea Tree Oil is the best thing to put on a bite to stop a bacterial infection in its tracts. I have been doing allot of research on Nutrition and its effects on the immune system. In the United States we eat too many over processed foods that have little or no valuable nutrition, or enzymes that are crucial for a healthy immune system, and the colon; What are your thoughts?
All the BEST,
Tom Schneider

Waynewells

February 8th, 2011 at 9:28 pm

Thanks Chaya for sharing a bit of your background with us. We are lucky to have you here as an American and as a CLL advocate you are a citizen of the world.

I found one case history of an Indian woman who drank the insecticide form of Neen extract in an attempted suicide. She was made quite ill but was reported as having fully recovered with no obvious harm done. A good sign (maybe) for trial participants.

WWW

jeanassuncao

March 4th, 2011 at 11:25 pm

Chaya,
Thank you so much for having this website. I want you to know how good it is to know that you are out there advocating for all of us. This trial sounds promising and I would love to participate. I was diagnosed with CLL almost two years ago and I am currently in the watch and wait stage. My counts are stable at 14,000 but my lymph nodes are starting to grow. This has me worried most of the time. I would like to know if anyone has had any success with shrinking nodes with green tea pills or other methods. Thanks!

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